On June 8, 2022 Chimeric Therapeutics Ltd (ASX:CHM) reported that it has formally submitted a pre-Investigational New Drug (IND) meeting request to the US Food and Drug Administration (FDA) for its cancer drug CHM 2101, a novel third-generation CDH17 CAR T cell therapy from the University of Pennsylvania (Press release, Chimeric Therapeutics, JUN 8, 2022, View Source [SID1234615796]).
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The pre-IND meeting request marks a major milestone for the development of CHM 2101 as it is the first formal meeting with the FDA on the development path to IND submission.
What’s more, the pre-IND meeting will provide Chimeric with the opportunity to discuss its IND plans with the FDA to gain feedback and insight prior to IND submission.
Looking ahead, the next step will be the submission of the CHM 2101 IND, enabling Chimeric to initiate the phase 1 clinical trial.
"First critical step"
Chimeric CEO and managing director Jennifer Chow said: "We are very excited to be taking this first critical step on the path to IND submission for CHM 2101,"
"We believe that CHM 2101 offers great promise for patients with gastrointestinal cancers and are very eager to move this asset to the clinic."
About CHM 2101
CHM 2101 (CDH17 CAR T) is a novel, third-generation CDH17 CAR T invented at the world-renowned cell therapy centre, University of Pennsylvania.
Preclinical evidence for CHM 2101 was published in March 2022 in Nature Cancer.
CHM 2101 (CDH17 CAR T) is in preclinical development with a planned phase 1 clinical trial in neuroendocrine tumours, colorectal, gastroesophageal and gastric cancer.